FDA Associate - Regulation, Labeling & Marketing (Mid-Level)

Job Overview

A law firm seeks a mid-level associate to join its Food & Drug Law practice in Washington, D.C. The practice advises companies in the food, dietary supplement, medical device, cosmetic, and OTC drug industries on regulatory, compliance, advertising, and enforcement matters. The role involves handling issues at the intersection of regulatory counseling, advertising substantiation, investigations, and litigation risk management.

Duties

• Provide FDA regulatory counseling for foods, dietary supplements, OTC drugs, cosmetics, and medical devices.
• Manage medical device regulatory matters, including premarket pathways and post-market obligations.
• Ensure FTC advertising and marketing compliance, including claims substantiation and promotional risk assessments.
• Handle National Advertising Division proceedings and compliance counseling.
• Conduct advertising claims substantiation and ingredient assessments.
• Address class action and pre-litigation consumer protection matters.
• Respond to state AG and DA inquiries, subpoenas, and investigations.
• Manage FDA inspections, warning letters, recalls, and enforcement actions.
• Oversee import/export issues and supply chain compliance.
• Conduct ingredient reviews and regulatory status assessments.
• Ensure California Proposition 65 compliance and GMP regulations adherence.
• Manage prescription drug labeling and promotional compliance.

Requirements

• Minimum of three years of experience in a law firm or comparable regulatory setting.
• Strong legal writing, research, and analytical skills.
• Collaborative, proactive, and detail-oriented approach.
• Ability to handle matters independently while working with senior attorneys and clients.

Education

• Juris Doctor degree from an accredited law school.

Certifications

• Admitted to and in good standing with the D.C. Bar (or eligible for prompt admission).

Skills

• Experience with FDA regulatory counseling and compliance strategy.
• Knowledge of medical device regulatory matters and promotional compliance.
• Understanding of FTC advertising and marketing compliance.
• Experience with class action and consumer protection matters.

Benefits

• Comprehensive health and wellness benefits.
• Opportunities for professional development and growth.
• Collaborative and inclusive work environment.

With a longtime DC presence, this strong and reputable firm takes an active role in community and pro bono activities. Recognizing the importance of longevity, this firm goes far to preserve its relationship with its associates. What does that mean for the firm employing hundreds of lawyers in a wide variety of practice areas? It means that associates are well trained and a family atmosphere is fostered. The firm is consistently ranked as one of the top 100 firms and generally considered a great place to work.